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Quality Operations Continuous Improvement Specialist

Quality Operations Continuous Improvement Specialist

SanofiFramingham, MA, US
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Quality Operations Continuous Improvement Specialist

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi MA BioCampus facilities. QA's main responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. The QA Process-Centric Unit (PCU) is a team that is responsible for the 24-hour QA performance of a defined manufacturing area to support operations and drive continuous improvement.

The Continuous Improvements (CI) Specialist role is to drive industrial excellence to achieve the PCU's strategic objective and performance ambition. The CI Specialist brings a high level of expertise and leadership in lean methodology, industrial performance, digital solutions, transformation and change management.

Main Responsibilities :

The main impact expected for the CI Specialist is to support the L1 PCU and L2 QA Operations team in performance and continuous improvement actions

  • Continuously analyses the performance of the PCU and supports the performance & continuous improvement actions.
  • Contributes to the definition of the PCU's trajectory with the PCU Manager and other CI Specialists in line with the site's compelling business needs.
  • Build, maintain and govern SMS standards used by the PCU to drive performance.
  • Improve data governance at PCU level.
  • Create, maintain capacity modeling for the QA Operations team to monitor efficiency and impact of CI initiatives and projects.
  • Project Manage CI Level 2 projects

Performance :

With the PCU Leads, develop the PCU's performance plan (duration less than 1 year, action carried out by the PCU and specific to the PCU).

  • Collects and analyses performance data directly from Gemba or through digital systems (deviations from standards, improvements, etc.)
  • Performs the cost analysis and confirms the capture of gains
  • Monitors the performance of actions identified and the achievement of outcomes, managing roadblocks & risk management
  • Executes and supports team members to execute CI initiatives and projects under the direction of department management
  • Ensures CI initiatives are delivered on-time and within established budgets, while delivering the committed value to the PCU performance
  • Leads the continuous improvement meetings at L1 PUC & L2 level
  • Provide leadership and structure to monitor PCU performance initiatives with quantified outcomes
  • Through a strong Gemba presence, conducts regular Gemba's to coach the teams on waste identification and perform confirmation processes.
  • Contributes to the network with the community of continuous improvement specialists to align practices and advance SMS standards
  • About You : Expectations :

  • Achieve SMS certification intermediate level within 6 months
  • Ability to analyze and make data driven proposals.
  • Ability to coordinate multiple CI programs / projects
  • Capability in data analysis and diagnostics
  • Good knowledge of plant operations
  • Strong communication skills
  • Ability to lead teams in a matrix organization
  • Ability to influence at multiple levels within an organization
  • High level of autonomy
  • Problem solving skills
  • Strong computer literacy
  • Field approach and relational ease
  • Good communication skills
  • Ability to prioritize and decide
  • Results / solutions / customer oriented
  • Education :

  • Associate's degree and 8 years of experience, or a bachelor's degree and 6 years of experience, or a master's degree and 4 years of experience, in Business, Engineering, Operations, Biology, Chemistry, or other similar relevant disciplines, preferably within a GMP manufacturing setting
  • Fluent English spoken and written
  • Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
  • Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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